Actively Recruiting
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-11-12
54
Participants Needed
1
Research Sites
7 weeks
Total Duration
Researchers are studying patients with infectious endocarditis (IE) and other severe infections that can cause major changes in the immune system, including a reduced immune function called injury-associated immunosuppression (IAI). This condition is linked to longer intensive care stays, more infections, and higher risk of death. The study aims to compare two established treatment protocols to see if using a cytokine adsorption filter during surgery can improve immune response in these seriously ill patients. The trial involves two treatment groups: one receiving the standard cardiac surgery protocol without adsorption, and the other receiving surgery with cytokine adsorption during the operation via an extracorporeal circuit. Both groups receive antibiotic therapy for up to 14 days before surgery. The adsorption treatment is studied as an additional step to potentially increase immune competence in patients undergoing surgical therapy for IE. Participants will be closely monitored before, during, and after surgery with assessments including immune cell markers (mHLA-DR expression), inflammatory markers like cytokines, organ function scores, length of ICU and hospital stay, and various therapy usage measures. Outcomes such as mortality rates and duration of supportive therapies will be tracked up to 90 days after ICU admission. The study uses random assignment to the two treatment protocols and involves regular blood tests and clinical evaluations to measure immune and organ function changes.
CONDITIONS
Cytokine REmoval in CRitically Ill PAtients Requiring Surgical Therapy for Infective Endocarditis (RECReATE)
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate post-operative period
Participants undergo routine cardiac surgery for infectious endocarditis. During surgery, some participants receive cytokine adsorption treatment while on the extracorporeal circuit.
1 surgical visit and hospital stay
Duration - Up to 90 days after surgery
Participants are monitored in the ICU and hospital for up to 90 days after surgery to assess recovery, organ function, and treatment outcomes.
Daily assessments in ICU and regular hospital visits during stay
Total: 1 location
1
Dept of Intensive Care Medicine
Bern, Switzerland, 3010
Actively Recruiting
J
Joerg C Schefold, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Fabian Gisler, Thibaud Spinetti, Gabor Erdoes...
https://pubmed.ncbi.nlm.nih.gov/32282706